You are here: Home > Prescription(RX) Drugs > A > Acetic Acid (Bausch & Lomb Incorporated)

Name:Acetic Acid
Manufacturer:Bausch & Lomb Incorporated
Category:Prescription Marketed Drugs


Acetic Acid 2% in AqueousAluminum Acetate Otic Solution

ACETIC ACID - acetic acid solution/ drops 
Bausch & Lomb Incorporated

----------

Acetic Acid 2% in Aqueous
Aluminum Acetate Otic Solution

Rx only

FOR USE IN THE EARS ONLY

NOT FOR USE IN THE EYES

DESCRIPTION:

Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution contains acetic acid 2% as the active ingredient, in a solution containing aluminum acetate (formed from Aluminum Sulfate, Calcium Carbonate, Glacial Acetic Acid), Boric Acid, Sodium Hydroxide and Purified Water. Sodium Hydroxide and/or Glacial Acetic Acid may be added to adjust the pH (3.5 to 5.0). Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is instilled in the external auditory canal. Acetic acid is an astringent and antimicrobial agent.

Chemically, acetic acid is C2H4O2 and has the following structural formula:

Acetic acid (Structural formula)

Molecular weight: 60.05

CLINICAL PHARMACOLOGY:

Acetic acid is antibacterial and antifungal and is effective against microorganisms (bacteria and fungi) that infect the ears of patients with acute diffuse external otitis. In vitro tests, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% acetic acid. Quantitative absorption of acetic acid 2% from external auditory canal is not known.

INDICATIONS AND USAGE:

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

CONTRAINDICATIONS:

Hypersensitivity to acetic acid or any of the ingredients in this product. Perforated tympanic membranes is considered a contraindication to the use of any external ear canal medication.

WARNINGS:

Avoid use or use with caution in patients with perforated tympanic membrane (See CONTRAINDICATIONS).

PRECAUTIONS:

General:

Care should be taken to assure that the Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution gets into the ear canal and stays in contact with the affected area long enough for the drug to act.

Discontinue promptly if sensitization or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No long term studies in animals have been performed to evaluate the carcinogenic potential of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.

ADVERSE REACTIONS:

Irritation may occur.

OVERDOSAGE:

No Toxic effect has been reported with overdosage of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.

DOSAGE AND ADMINISTRATION:

The patient should lie on the side with the affected ear uppermost. Instill 4 to 6 drops into the external auditory canal and maintain this position for 5 minutes. Repeat the procedure every 2 to 3 hours.

HOW SUPPLIED:

Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is available in 60 mL plastic squeeze bottle with otic tip.

Prod. No. 06620.

Storage:

Store between 15˚ - 30˚ C (59˚ - 86˚ F).

PROTECT FROM FREEZING

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised January 2008

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9066901

Principal Display Panel

Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution (Carton, 60 mL - Bausch & Lomb)

NDC 24208-615-77

[icon- ear]

Acetic Acid 2%
in Aqueous Aluminum Acetate Otic

SOLUTION

(Sterile)

USE IN EARS ONLY

CAUTION: NOT FOR OPHTHALMIC USE

Rx only

60 mL

Bausch & Lomb


ACETIC ACID 
acetic acid solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-615
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE  
BORIC ACID  
CALCIUM CARBONATE  
ACETIC ACID  
WATER  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-615-77 1 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 60 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (24208-615-77)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040063 02/25/1994

Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 807927397 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Holland Company 044985778 MANUFACTURE

Revised: 03/2011 Bausch & Lomb Incorporated



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback